Description:
As Program Leader, you will be accountable for the end-to-end strategic and operational leadership of one or more in vitro diagnostic development programs, including Clinical Trial Assays, tumor profiling tests, Companion Diagnostics, and software as a medical device. You will ensure programs are co-developed, validated, and submitted on time and in alignment with each biopharma partner’s drug development timeline. This role requires deep knowledge of IVD and CDx development, strong biopharma customer management skills, and the ability to orchestrate cross-functional teams across development, verification and validation, clinical, regulatory, and commercial workstreams.
The value you add
- Define and own the design and development strategy for IVD, CTA, tumor profiling, CDx, and/or SaMD programs, aligning analytical and clinical validation and regulatory timelines with biopharma drug development milestones, including IND, Phase I/II/III, BLA, NDA, and MAA.
- Build trusted biopharma partnerships as the primary project contact, maintaining transparency on status, risks, decisions, co-development agreements, technical feasibility scopes, and joint development plans in collaboration with Biopharma Business and Legal.
- Lead internal and joint governance—including portfolio reviews, business stage gates, design reviews, Joint Steering Committees, and Joint Development Teams—to drive aligned, timely decision-making.
- Integrate Bioinformatics and Assay Development, Verification and Validation, Clinical Operations, Regulatory Affairs, Quality Assurance, Manufacturing, Product Management, and Biopharma teams around a coherent program strategy, milestones, resources, and shared accountability.
- Deliver diagnostic programs from requirements definition through product development, verification and validation, regulatory submission, and commercial launch while managing timelines, budgets, risks, resources, and contingency plans.
Requirements
We know that every background is different, but to be best set for success we see you bringing:
- 8+ years of experience in diagnostic product development or program/project ownership across IVD, CDx, or clinical laboratory assays, including at least 3 years in cross-functional project or program leadership.
- A demonstrated track record of delivering an IVD or CDx program through FDA approval or CE marking, or a CTA through a pivotal clinical trial.
- Deep knowledge of IVD and CDx development, including assay and bioinformatics development, analytical and clinical validation, design controls, regulatory interactions, and global regulatory strategy.
- Experience managing budgets, resource planning, technical and regulatory risks, and complex external biopharma partnerships in a matrixed, multi-partner environment.
- The ability to move between high-level business strategy and tactical daily program operations, supported by strong technical communication, influencing, negotiation, and conflict-resolution skills.
- A solid understanding of drug-diagnostic co-development and the regulatory interdependencies between CDx and drug approval; familiarity with EU IVDR and FDA requirements is preferred.
- Oncology therapeutic area experience and a hands-on technical background in one or more diagnostic platforms are preferred.
- A B.S. degree or equivalent is required; a PhD, MSc, or equivalent degree in molecular biology, biochemistry, analytical chemistry, genomics, pathology, or a related life sciences discipline is preferred.